Identity
- Trade Name
- HYGITECH FDA UDI
- Generic Name
- Bone cutter FDA UDI
- Device Name
- V-LC2R surgery tip compatible Satelec HYGITECH Reference: HY-98125 Very fine flat cutting chisel, 45° to the right. Used for root osteoplasty, it facilitates access to posterior areas and confined spaces. Its fineness allows it to elaborate a delicate work without risk of degrading the bone table. This surgery tip offers the surgeon precision and comfort in sites with reduced visibility Length: 10 mm FDA UDI
- Model / Reference
- HY-98125 FDA UDI
- Description
- V-LC2R surgery tip compatible Satelec HYGITECH Reference: HY-98125 Very fine flat cutting chisel, 45° to the right. Used for root osteoplasty, it facilitates access to posterior areas and confined spaces. Its fineness allows it to elaborate a delicate work without risk of degrading the bone table. This surgery tip offers the surgeon precision and comfort in sites with reduced visibility Length: 10 mm FDA UDI
Identifiers
- Catalog Number
- HY-98125 FDA UDI
- Primary DI / UDI-DI
- 03615140005470 FDA UDI
- FDA Product Code
- EJB FDA UDI
- GMDN Term
- Bone cutter FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Bone cutter
Hygitech by Hygitech — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone cutter.
- Zimmer Persona Knee System — Zimmer, Inc. · Class II
- Intervertebral Disc Preparation Instruments — ALPHATEC SPINE, INC. · Class I
- Novel — ALPHATEC SPINE, INC. · Class I
- Battalion — ALPHATEC SPINE, INC. · Class I
- Intervertebral Disc Preparation Instruments — ALPHATEC SPINE, INC. · Class I
- Battalion — ALPHATEC SPINE, INC. · Class I
- IdentiTi — ALPHATEC SPINE, INC. · Class I
- Park Dental Research Corp. — Park Dental Research Corp · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hygitech
Sources (1)
- FDA UDI 26b2810f-e8ad-4677-915d-e494def803b4 34 fields · synced Jun 1, 2026